Recruiting

Physical Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT02283996

Conditions

Adhesive Capsulitis

Frozen Shoulder

Shoulder Frozen

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Physical Therapy

Depot Methylprednisolone

Study Details

Brief summary:

The purpose of this study is to identify individuals 18 or older who have diagnostic presentation of adhesive capsulitis and randomize them into two arms, distinguished by use of physical therapy and steroid injections compared with steroid injections followed by watchful waiting. This prospective study will be used to determine whether there is a significant impact on patient outcome and whether the additional financial burden is justified. There are no experimental interventions for this study. The use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are offered following the standard of care for adhesive capsulitis. Our hypothesis is that patients will not have a significant difference in outcome between the two study arms. One group will undergo regular physical therapy with corticosteroid injections (Arm 1) and the other will have steroid injections during the inflammatory phase only and then be regularly observed (Arm 2). We also hypothesize there will be a significant financial burden associated with the PT arm that is not justified with the possibility of increased symptom reports in that arm.

Conditions

Adhesive Capsulitis

Frozen Shoulder

Shoulder Frozen

Study ID

NCT02283996

Start date

Nov, 2014

Status verified date

Oct, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patient must be 18 years or older
  • Must meet the following definition for adhesive capsulitis as defined by the American Academy of Orthopedic Surgeons: Self-limiting condition resulting from any inflammatory process about the shoulder in which capsular scar tissue is produced, resulting in pain and limited range of motion; also called frozen shoulder
  • Must be amenable to randomization into either cohort

Exclusion Criteria:

  • Non-English speaking patients
  • Pregnant women (women of childbearing potential will be advised to undergo regular pregnancy testing)
  • Patients who had previously undergone operative therapy for the condition

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Physical Therapy with Steroid Injection

Patients will undergo regular physical therapy as defined by the standard of care at Massachusetts General Hospital for Adhesive Capsulitis (Frozen Shoulder). If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

experimental: Watchful Waiting with Steroid Injection

Patients will undergo no therapeutic intervention outside of steroid injection. If they are in the inflammatory phase of the condition, they will receive 40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine.

Interventions

Physical Therapy

The following link contains the protocol for physical therapy that will be used in the study. There are no other ancillary devices or drugs used in this study aside from the depot methylprednisolone listed under interventions.

Brigham and Women's/Massachusetts General Standard of Care Guidelines for Physical Therapy in Treatment of Adhesive Capsulitis:

http://www.brighamandwomens.org/Patients\_Visitors/pcs/rehabilitationservices/Physical%20Therapy%20Standards%20of%20Care%20and%20Protocols/Shoulder%20-%20Adhesive%20capsulitis.pdf

Depot Methylprednisolone

40 mg of depot methylprednisolone in solution with 2 cc of 1% lidocaine

Primary outcome measure

  • Functional outcome based on the American Shoulder and Elbow Surgeons Standardized Questionnaire [ Time Frame: November 2014 to November 2023 ]

Central Contacts and Locations

Central contacts

Scott D Martin, MD

617-732-5329sdmartin@partners.org

Locations

MGH, Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Scott D Martin, MD

SDMARTIN@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

  • Adhesive Capsulitis
  • Frozen Shoulder
  • Shoulder Frozen
  • Physical Therapy
  • Corticosteroid Injections
  • Hydrodilation, Hydro-dilation
  • Watchful Waiting
  • Prospective
  • Glenohumeral Ligament

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-27.